Osimertinib Impurity 76 CAS CATO-C4X-204576

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-204576
Molecular FormulaC21H21N5O2
Molecular Weight375.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Osimertinib Impurity 76 CAS CATO-C4X-204576 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Osimertinib Impurity 76.

CATO supplies Osimertinib Impurity 76 (CAS CATO-C4X-204576), a pharmacopoeial impurity reference standard (molecular formula C21H21N5O2, MW 375.42 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C21H21N5O2, Osimertinib Impurity 76 contains a steroid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 375.42 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

CATO manufactures Osimertinib Impurity 76 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC21H21N5O2
Molecular Weight375.42 g/mol
AppearancePale yellow to yellow crystalline powder
Purity≥95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms5

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